Milan Vican
Toronto - Willing To Relocate,ONTARIO
Summary
With over seven years of experience in project management and execution in GMP-regulated pharmaceutical manufacturing, I am a skilled technical expert and versatile business operations specialist with a background in optimizing operational processes and implementing effective business solutions. Skilled in project management, strategic planning, and process improvement, consistently delivering results that drive efficiency and reduce costs. Strong analytical abilities and problem-solving skills contribute to successful project outcomes and positive impacts on overall business performance.
I possess strong project management skills and specialize in equipment start-up, qualification, process validation, and the commissioning of both liquid and solid dosage systems.
I have effectively led cross-functional teams, ensuring that engineering solutions align with business objectives and compliance goals, while consistently delivering complex projects on time and within budget.
Overview
7
7
years of professional experience
Work History
Consultant III
Hyde Engineering-Consulting (SANOFI)
North York - Toronto
05.2024 - Current
- Assigned to - B200 Bulk Vaccine Manufacturing Capital Expansion Project
- Execution of validation protocols, end to end (utilizing KNEAT) to include qualification summary reports
- Working knowledge of cGMPs to be able to provide guidance to team members and clients
- Commissioning of process equipment and systems (upstream support systems)
- Shake down of process equipment and support systems, static and dynamic testing
- Performed IQ/OQ execution and qualification summary report
- Provided extensive troubleshooting throughout the qualification process to address design issues
- Performed SAT execution for process CIP skids (10 circuits)
- Drafted impact assessment and conducted retesting and deviation closure
- Improving facility efficiency and reduce resource usage
- Sanofi Pasteur, North York
Validation Specialist
New Beta Innovation Canada Limited
Burnaby, Canada
02.2023 - 10.2023
- Responsible to maintaining the equipment validation program and review of validation documents.
- Prepared and reviewed URS, DQ, FDS, FAT/SAT, IOQ, PQ, validation plans, risk assessments, validation summary reports
- Perform requalification and computer systems validation
- Supported execution of validation activities, periodic review and requalification program.
Senior Validation Engineer
Syntegon
10.2018 - 11.2022
- Served as Project Leader for Bosch filling equipment to include calibration, FAT/SAT, cycle development, VHP, IQ/OQ/PQ qualification for international Bosch clients
- Actively participated in the commissioning phase, directly interfacing with customers to define clear and achievable milestones and integrating their expectations into validation and project timelines.
- Visited 30 clients to support Bosch projects (vials, cartridges, prefilled syringes).
- SME for Bosch fill-finish lines (washers, tunnel sterilizers, filling lines, isolators, cappers).
- Authored qualification and validation protocols for sterile filling equipment, verified compliance with internal policies, regulatory requirements, and external safety policies.
- Project manager and lead (team lead) to develop the SMEPAC Test program.
- Valicare s.r.o, formerly Bosch GmbH Packaging Technology
Project manager for strategic projects
MSM Group Defense (Czechoslovak Group)
Dubnica nad Vahom
04.2024 - 2024
- Management & Coordination of business cases across companies in the group with business partners
- Coordination of tasks in the project team
- Developing business relations, conducting business meetings and maintaining standard with partners
- Monitored project progress, identifying risks and implementing mitigation strategies.
- Facilitated communication between stakeholders to ensure project alignment.
Education
Masters - CHEMICAL TECHNOLOGIES, ANALYTICAL CHEMISTRY
SLOVAK UNIVERSITY OF TECHNOLOGY IN BRATISLAVA
01.2018
Bachelor - BIOTECHNOLOGY
SLOVAK UNIVERSITY OF TECHNOLOGY IN BRATISLAVA
01.2016
Skills
- Assessments
- Analytical and critical thinking
- Attention to detail
- Project management
- Effective time management
- cGMP compliance
- Equipment qualification
- Process optimization
- Reports and documentation
- Validation protocols
Languages
English
Full Professional
Slovak
Native/ Bilingual
Czech
Professional
German
Elementary
Timeline
Consultant III
Hyde Engineering-Consulting (SANOFI)
05.2024 - Current
Project manager for strategic projects
MSM Group Defense (Czechoslovak Group)
04.2024 - 2024
Validation Specialist
New Beta Innovation Canada Limited
02.2023 - 10.2023
Senior Validation Engineer
Syntegon
10.2018 - 11.2022
Masters - CHEMICAL TECHNOLOGIES, ANALYTICAL CHEMISTRY
SLOVAK UNIVERSITY OF TECHNOLOGY IN BRATISLAVA
Bachelor - BIOTECHNOLOGY
SLOVAK UNIVERSITY OF TECHNOLOGY IN BRATISLAVA